Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration

February 19, 2016 updated by: Kee Myung Lee, Ajou University School of Medicine

The Effect of Newly Designed Covered Self-expandable Metallic Stents Insertion Using Clips and Suture Materials for Preventing Migration in Benign Stricture of Gastroduodenal Anastomosis: a Pilot Study

In patients of subtotal gastrectomy with Billroth-I or Billroth-II anastomosis, Anastomosis site stricture is very severe complication. It can improve by temporary through the scope covered metallic stent. It is very effective procedure about the stricture. But stent migration is very severe complication. Herein the investigators suggest newly method to prevent the stent migration. Fixation of stent by hemoclip is effective method to prevent stent migration. But it is difficult to remove stent after resolved stricture. So the investigators add the suture between hemoclip and stent. And the investigators cut the suture when stent removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Suwon, Korea, Republic of, 443-721
        • Ajou University Hospital
    • Gyeong-gi do
      • Suwon, Gyeong-gi do, Korea, Republic of, 443-380
        • Ajou University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subtotal gastrectomy with Billroth-I or Billroth-II anastomosis
  • symptom of gastric outlet obstruction
  • anastomosis site stricture after surgery

Exclusion Criteria:

  • patients of the impossible stent insertion due to other complication
  • foreigner
  • no agree a concent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anastomosis site stricture
anastomosis site stricture after subtotal gastrectomy with Billroth-I anastomosis
Procedure: deployment of through the scope covered metallic stent at the stricture site
Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site
Device: Covered Self-expandable Metallic Stents

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of symptom (Resolving anastomosis site stricture)
Time Frame: Up to 1 month
Improvement of food intake. It was measured by the gastric outlet obstruction scoring system (GOOSS) score, with 0 = no oral intake, 1 = liquid diet, 2 = soft diet, and 3 = regular diet.
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications associated with the procedure
Time Frame: Up to 1 month (time of stent removal)
Check all the complications associated with the procedure (e.g. procedure failure, stent migration, no improvement of symptom, etc.)
Up to 1 month (time of stent removal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: Sun Gyo Lim, M.D., Ajou University School of Medicine
  • Principal Investigator: Ki Seong Lee, M.D., Ajou University School of Medicine
  • Principal Investigator: Joon Koo Kang, M.D., Ajou University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 16, 2014

First Posted (Estimate)

July 18, 2014

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

February 19, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AJIRB-MED-MDB-14-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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